ARTIFLEX CHONDRO

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ARTIPHLEX CHONDRO (ARTIPHLEX CHONDRO)

Composition:

Active substance: chondroitin sulfate;

1 ml of solution contains sodium chondroitin sulfate 100 mg;

Excipients: benzyl alcohol, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear, colorless or slightly yellowish liquid with the odor of benzyl alcohol.

Pharmacotherapeutic group. Drugs affecting the musculoskeletal system. Chondroitin sulfate. ATC code M01AX25.

Pharmacological properties.

Pharmacodynamics.

The active ingredients of the medicinal product are sodium salts of chondroitin sulfate A and C (average molecular weight 11,000 daltons). Chondroitin sulfate is a high-molecular-weight glycosaminoglycan. It is a key component of proteoglycans, which, together with collagen fibers, form the cartilage matrix.

The drug inhibits the degeneration process and stimulates regeneration of cartilage tissue, exerting chondroprotective, anti-inflammatory, and analgesic effects. It replaces chondroitin sulfate in joint cartilage degraded by pathological processes. It suppresses the activity of enzymes causing degradation of joint cartilage; inhibits metalloproteinases, particularly leukocyte elastase. It reduces hyaluronidase activity. Partially blocks the release of free oxygen radicals; promotes inhibition of chemotaxis and antigenic determinants. Stimulates proteoglycan production by chondrocytes. Influences calcium-phosphate metabolism in cartilage tissue. Helps restore the mechanical and elastic integrity of the cartilage matrix. Anti-inflammatory and analgesic effects are achieved by reducing the release of inflammatory mediators and pain factors into the synovial fluid by synoviocytes and macrophages of the synovial membrane, as well as by inhibiting the secretion of leukotriene B and prostaglandin E.

The use of the drug promotes restoration of the joint capsule and articular cartilage surfaces, prevents compression of connective tissue, acts as a lubricant for joint surfaces, normalizes the production of synovial fluid, improves joint mobility, reduces pain intensity, and enhances quality of life.

The drug slows down bone resorption and reduces calcium loss, while accelerating bone tissue regeneration processes.

Pharmacokinetics.

After intramuscular administration, chondroitin sulfate penetrates into the synovial fluid. Cmax in synovial fluid is reached within 4–5 hours after injection. It is eliminated from the body within 24 hours. Excretion occurs predominantly via the kidneys.

Clinical characteristics.

Indications.

Degenerative-dystrophic joint and spinal disorders (primary osteoarthritis, intervertebral osteochondrosis, osteoarthritis), osteoporosis, periodontal diseases, fractures (to accelerate formation of bone callus), as well as for treatment of post-surgical complications following joint surgery.

Contraindications.

Hypersensitivity to any component of the drug, predisposition to bleeding, thrombophlebitis, renal failure, hepatic insufficiency in decompensated stage, pregnancy, lactation, pediatric age.

Use with caution: in patients with coagulation disorders; diabetes mellitus; individuals with increased body weight; renal function impairment; women planning pregnancy.

Interaction with other medicinal products and other types of interactions.

When used concomitantly with glucocorticoids and nonsteroidal anti-inflammatory drugs, chondroitin sulfate may reduce the need for these agents, as well as for analgesics. A synergistic effect is observed when used simultaneously with glucosamine and other chondroprotective agents. Treatment efficacy is enhanced by enriching the diet with vitamins A and C, and salts of manganese, magnesium, copper, zinc, and selenium.

When administered concomitantly with acetylsalicylic acid or other anticoagulants or antiplatelet agents, monitoring of blood coagulation is recommended. When used concomitantly with tetracyclines, chondroitin may affect tetracycline concentration in blood serum.

Special precautions.

To achieve a stable clinical effect, at least 25 injections of the drug are required. The effect persists for many months after completion of treatment. To prevent relapses, repeated treatment courses should be administered. Dose escalation under physician supervision is recommended for patients with excess body weight, gastric or duodenal peptic ulcer, those concurrently using diuretics, and at the beginning of treatment if a faster clinical response is needed.

Treatment should be discontinued in case of allergic reactions or hemorrhage.

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e., it is practically sodium-free.

Use during pregnancy or breastfeeding.

Do not use during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

There are no restrictions regarding driving or operating complex machinery during use of this medicinal product.

Method of Administration and Dosage.

Administer the drug intramuscularly to adults at a dose of 1 ml every other day. In case of good tolerance, increase the dose to 2 ml starting from the fourth injection. Treatment course – 25–35 injections. Repeat courses – every 6 months.

Children. There is no experience with the use of the drug in children.

Overdose.

To date, there have been no reports of overdose symptoms associated with the use of this drug. Nevertheless, it can be assumed that exceeding the daily dose may enhance the manifestation of the drug's adverse effects. Treatment is symptomatic.

Side effects.

In patients with increased sensitivity to the drug, the following adverse reactions may occur:

Immune system disorders: allergic reactions, anaphylactic shock, angioneurotic edema;

Skin and subcutaneous tissue disorders: skin rashes, pruritus, erythema, urticaria, dermatitis, alopecia;

Injection site reactions, including redness and itching;

Gastrointestinal disorders: nausea, vomiting, abdominal pain, flatulence, dyspeptic symptoms, diarrhea;

Other: visual disturbances, keratopathy, dizziness, peripheral edema.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Incompatibility. No cases of incompatibility have been documented since the beginning of chondroitin sulfate use (1960); however, mixing solutions of high-molecular-weight polysaccharides (including chondroitin sulfate) with solutions of other medicinal products should be avoided.

Packaging. 2 mL in vials, pack of 5, 10 in a box; 5, 5×2, 10 in blisters in a box. 2 mL in pre-filled syringes with needles, pack of 1, 5, 1×5 in blisters in a box.

Prescription status. Prescription only.

Manufacturer.

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business.

Ukraine, 61013, Kharkiv region, Kharkiv, Shevchenka Street, 22.